SOFTSITE (HEFILCON A) CONTACT LENS

FDA Premarket Approval N17793 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceSOFTSITE (HEFILCON A) CONTACT LENS
Generic NameLenses, Soft Contact, Daily Wear
ApplicantUNILENS CORPORATION USA
Date Received1985-09-16
Decision Date1986-01-22
PMAN17793
SupplementS010
Product CodeLPL 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address UNILENS CORPORATION USA 10431 72nd Street North largo, FL 33777

Supplemental Filings

Supplement NumberDateSupplement Type
N17793Original Filing
S014 1987-04-08 Normal 180 Day Track
S013 1987-04-08 Normal 180 Day Track
S012 1986-09-03 Normal 180 Day Track
S011 1985-09-16
S010 1985-09-16
S009 1985-08-19
S008 1983-11-04
S007
S006 1983-07-11
S005 1982-01-08
S004 1980-11-06
S003 1980-05-28
S002
S001 1979-10-22

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